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Santen1 day ago

Complaint Coordinator

$47,031–$70,547 year

On-site · Miami, Florida, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Large
Industry
PHARMA

Job Summary

Complaint Coordinator to manage and process product complaints for PRESERFLO MicroShunt at Santen InnFocus Miami; responsibilities include complaint handling, investigation, testing returned devices, root cause investigations, determine reportability, cross-functional collaboration with regulatory, clinical, and technical teams, maintain complaint databases and documentation, ensure accurate data entry, support internal/external audits, and contribute to continuous improvement. Requires a Bachelor’s degree and 5+ years in the medical device industry, knowledge of ISO 13485, EU MDR, and 21 CFR Part 820, experience with complaint handling or returned goods, strong MS Office skills, English fluency, and understanding of ophthalmic terminology a plus.

Required Qualifications

  • Bachelor’s degree or equivalent experience
  • Minimum 5 years’ experience in the medical device industry
  • Knowledge of ISO 13485, EUMDR, and 21 CFR Part 820
  • Experience with complaint handling or returned goods preferred
  • Strong MS Office skills (Word, Excel, PowerPoint, Outlook)
  • Understanding of ophthalmic terminology is a plus
  • Strong communication and organizational skills
  • Fluent in English (written and spoken)
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$47k – $71k / yr

Complaint Coordinator · Santen

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